BioStrategics Consulting Ltd provides a range of management-level clinical development consulting services to the pharmaceutical, biotechnology and medical device industries, including:
- Clinical development strategy and management, especially for development-stage companies
- Conceptualization, implementation, and management of Phase 1, Phase 2, first-in-man, and proof-of principle clinical trials
- IND planning and preparation
- FDA and other regulatory authority submissions, meetings, and related interactions
- Clinical strategic planning for small molecules, biotechnology products, immunotherapeutic agents, novel drug delivery technologies, and medical devices in virtually all therapeutic areas
- New technology assessment, due diligence, and program planning
- Clinical development advisory services to senior-level management (CEO, COO, CSO, BOD).
Since its founding in 1999, BioStrategics Consulting Ltd has provided clinical research leadership for:
- More than 20 Investigational New Drug applications, Clinical Trial Applications, or similar regulatory submissions
- Numerous first-in-man clinical trials, both in healthy volunteer and in target patient populations
- Proof-of-principle clinical trials in a variety of therapeutic areas, including oncology, rheumatology, dermatology, ophthalmology, autoimmune disease, infectious disease, immunotherapy, endocrinology/metabolic disease, and hematology
- Clinical trial operational teams on 4 continents
- Multiple pre-IND and milestone meetings with FDA reviewing divisions
- Due diligence, business development, partnership, and corporate strategic analysis projects of preclinical-, clinical-, and commercial-stage projects.
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